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Poor understanding of prescription drug label (PDL) instructions can lead to medication errors, suboptimal treatment (side) effects, and non-adherence. A personalized medication hard-copy overview listing PDL instructions and visual information may support patients in their medication use. This study aimed to investigate the comprehensibility of PDL instructions on a personalized medication overview compared to usual-care PDL instructions presented on a medication box. A hypothetical-online-experiment was set up, comparing groups of respondents exposed vs not exposed to the medication overview and who received PDL instructions for three, five, or eight medications. Participants were divided randomly in six groups. Online questionnaires were sent to a stratified sample of 900 members from the Nivel Dutch Healthcare Consumer Panel. Outcome measures included comprehension of instructions for medication use, e.g. how often, dose timing, usage advice and warnings for a medication with simple use instructions (omeprazol) and more complex use instructions (levodopa/carbidopa (L/C)). To analyze differences between experimental conditions ANOVA testing was used. 604 respondents (net response 67%) completed the questionnaires. Respondents exposed (E) to the overview gave a higher proportion of correct answers compared to non-exposed (NE) respondents for usage advice (L/C: mean 0.83, SD 0.4 E; 0.03, SD 0.2 NE, p < 0.001; omeprazol: mean 0.85, SD 0.4 E; 0.10, SD 0.3 NE, p < 0.001). Both groups gave the same proportion of correct answers (mean 0.80, SD 0.4, p = 1.0) for dose timing of omeprazol. More NE respondents gave correct answers for how often (mean 0.85, SD 0.4 NE; mean 0.76, SD 0.4 E, p = 0.02) and dose timing (mean 0.92, SD 0.3 NE; mean 0.86, SD 0.4 E, p = 0.04) of L/C. No differences were found regarding number of medications nor were interaction effects found between the number of medications and information type. As a medication overview contains additional information, it can be a good addition in supporting patients in their medication use compared to usual-care PDLs. Future research should focus on identifying patient groups who might benefit more from a medication overview, by testing the effect of such overview on this group.

IntroductionPatients receive information about their medication from different sources, including prescription labels. These labels are physically attached to each package dispensed to patients and contain the most important instructions on how to use the medication correctly. However, many patients experience difficulties in understanding and applying the instructions on these labels correctly, especially patients with limited health literacy. The aim of this study is to investigate the comprehensibility of prescription label instructions among patients with adequate and limited health literacy skills, and to implement improvements in primary health care.MethodsWe used a mixed-methods approach, which consisted of four phases. Phase 1 (desk research) was divided into a systematic literature review on the comprehensibility of prescription label instructions (1a) and a content analysis of the textual elements in Dutch prescription label instructions (1b). In phase 2 (patient studies), semi-structured interviews were conducted to investigate the comprehensibility of seven prescription labels among patients with different health literacy skills (2a), and a quantitative study in which the comprehensibility of six optimized prescription labels was compared among patients with different health literacy skills (2b). Patient studies were conducted in eight Dutch pharmacies. In phase 3 optimized prescription label instructions were implemented in national medication databases which has been supported by a guideline (3a), and education of pharmacy workers (3b). Phase 4 consists of evaluating the optimized prescription label instructions by experiences from patients and pharmacists.Anticipated ResultsThis mixed-methods approach will result in scientific publications of the individual studies, and a guideline on how to compose comprehensible prescription label instructions to be put on medication packages. Optimized prescription label instructions will be implemented in national medication databases.DiscussionThis protocol describes a mixed-method research to compose and implement comprehensible prescription label instructions and will lead to knowledge about the comprehensibility of textual elements in these labels, with specific attention for patients with limited health literacy. Implementation of optimized prescription label instructions will lead to a better understanding of them, which may contribute to improved medication adherence. A limitation is that non-textual aspects of prescription labels are not investigated.

Medication non-adherence is a major public health problem that has been termed an ‘invisible epidemic’. Non-adherence is not only associated with negative clinical consequences but can also result in substantial healthcare costs. Up to know, effective adherence interventions are scarce and a more comprehensive model of adherence determinants is required to target the determinants for not taking the medication as prescribed. Current approaches only included explicit attitudes such as self-reported evaluations of medication as determinants, neglecting the role of associative processes that shape implicit attitudes. Implicit processes can predict daily behavior more accurately than explicit attitudes. Our aim is to assess explicit and implicit attitudes towards medication and explore the relation with beliefs, adherence and clinical (laboratory) outcomes in chronically ill patients. 52 Rheumatic Arthritis (RA) patients’ attitudes towards Methotrexate (MTX) were explicitly (self-reported) and implicitly (Single-Category Implicit Association Test) assessed and related to the Beliefs about Medicine Questionnaire, the Compliance Questionnaire on Rheumatology and laboratory parameters (Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP)). Results show that explicit attitudes were positive and health-related. Implicit attitudes were however negative and sickness-related. Half of the patients displayed explicitly positive but implicitly negative attitudes. Explicit attitudes were positively related to ESR. A positive relationship between implicit attitudes and disease duration was observed. In this study, we have obtained evidence suggesting that the measurement of implicit attitudes and associations provides different information than explicit, self-reported attitudes toward medication. Since patients’ implicit attitudes deviated from explicit attitudes, we can conclude that the relationship between implicit attitudes and medication adherence is worthwhile to be further explored. With this information we can improve our understanding of the subconscious, automatic processes underlying adherence and we can develop interventions that target these implicit attitudes.

Introduction: Patients receive information about their medication from different sources, including prescription labels. These labels are physically attached to each package dispensed to patients and contain the most important instructions on how to use the medication correctly. However, many patients experience difficulties in understanding and applying the instructions on these labels correctly, especially patients with limited health literacy. The aim of this study is to investigate the comprehensibility of prescription label instructions among patients with adequate and limited health literacy skills, and to implement improvements in primary health care. Methods: We used a mixed-methods approach, which consisted of four phases. Phase 1 (desk research) was divided into a systematic literature review on the comprehensibility of prescription label instructions (1a) and a content analysis of the textual elements in Dutch prescription label instructions (1b). In phase 2 (patient studies), semi-structured interviews were conducted to investigate the comprehensibility of seven prescription labels among patients with different health literacy skills (2a), and a quantitative study in which the comprehensibility of six optimized prescription labels was compared among patients with different health literacy skills (2b). Patient studies were conducted in eight Dutch pharmacies. In phase 3 optimized prescription label instructions were implemented in national medication databases which has been supported by a guideline (3a), and education of pharmacy workers (3b). Phase 4 consists of evaluating the optimized prescription label instructions by experiences from patients and pharmacists. Anticipated Results: This mixed-methods approach will result in scientific publications of the individual studies, and a guideline on how to compose comprehensible prescription label instructions to be put on medication packages. Optimized prescription label instructions will be implemented in national medication databases. Discussion: This protocol describes a mixed-method research to compose and implement comprehensible prescription label instructions and will lead to knowledge about the comprehensibility of textual elements in these labels, with specific attention for patients with limited health literacy. Implementation of optimized prescription label instructions will lead to a better understanding of them, which may contribute to improved medication adherence. A limitation is that non-textual aspects of prescription labels are not investigated. [ABSTRACT FROM AUTHOR]